A comparative study of the effect of traditional and simulation training methods on the correct technique of inhalation drug use in nursing students
Design
In this study, a clinical trial with a control group, with parallel groups, double-blind, randomized, the samples were assigned to the intervention and control groups based on simple random sampling. The sample size was calculated for each group of 39 people.
Settings and conduct
Each group was given 20 minutes to practice the technique of using the devices in a group and then to be evaluated among their peers. Students in the intervention group have 5 minutes to teach the simulated patient and The rest of the students will observe the patient counseling process until the patient completes all the steps correctly. Patients in the study will act on scenarios pre-designed by the researcher. So that in each performance, the patient will intentionally perform one or more steps of the technique based on the developed scenario, and the student must identify and correct the incorrect technique to the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Satisfaction to participate in the study; Do not participate in other classes and educational programs; Lack of experience and work experience of students from the inhaled devices in the hospital or outside it, (except internship)
Exclusion criteria: Having a degree from another field;The student's personal experience in using inhalers for himself or a family member
Intervention groups
The training control group will use the traditional method and the intervention group (simulation) will use simulated scenarios and counseling with the simulated real patient.
Main outcome variables
The correct technique of using inhaled drugs that was done before the intervention and one week after the intervention and based on the checklist.
General information
Reason for update
Acronym
.
IRCT registration information
IRCT registration number:IRCT20120409009422N10
Registration date:2021-02-28, 1399/12/10
Registration timing:retrospective
Last update:2021-02-28, 1399/12/10
Update count:1
Registration date
2021-02-28, 1399/12/10
Registrant information
Name
Aram Feizi
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1336 5836
Email address
aramfeizi@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-11-10, 1399/08/20
Expected recruitment end date
2020-12-10, 1399/09/20
Actual recruitment start date
2020-12-05, 1399/09/15
Actual recruitment end date
2021-01-09, 1399/10/20
Trial completion date
2021-01-09, 1399/10/20
Scientific title
A comparative study of the effect of traditional and simulation training methods on the correct technique of inhalation drug use in nursing students
Public title
Effect of traditional and simulation training methods on the correct technique of inhalation drug use
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Do not participate in other classes and educational programs
Lack of experience and work experience of students from the inhaled devices in the hospital or outside, (except internship)
Exclusion criteria:
Having a degree from another field
The student's personal experience in using inhalers for himself or a family member
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Actual sample size reached:
81
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, after coordination with the director of the relevant group, 81 nursing students of the 4th and 5th semesters of nursing in the first semester of 1399 will be included in the study as a census based on the inclusion and exclusion criteria. 4th and 5th semester students According to the grouping, the nursing group manager will be divided into 11 groups (minimum 4 to maximum 10 people). Then, out of these 11 groups, six groups will be randomly assigned to the simulation group (intervention) and five groups to the traditional group (control) using luck coins. Therefore, the randomization method is simple and group randomization unit.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the person evaluating the outcome and the person analyzing the data are blind, and the participants in this study are not blind, and in this sense it is a one-sided blind study.
Placebo
Not used
Assignment
Parallel
Other design features
.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of urmia university of medical sciense
Street address
urmia, resalat Blvd, Campus emergency, urmia university of medical sciense
City
urmia
Province
West Azarbaijan
Postal code
iran
Approval date
2020-09-16, 1399/06/26
Ethics committee reference number
IR.UMSU.REC.1399.203
Health conditions studied
1
Description of health condition studied
The correct technique of inhalation drug use
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The correct technique of inhalation drug use
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Checklist consisting of professional standards related to the correct technique of using inhaled drugs
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, training will be given in the traditional way (lecture with slide show) and practical training, with evaluation / training by peers.
Category
N/A
2
Description
Intervention group:In this group (simulation) in addition to practical training, simulated scenarios and simulated real patient counseling will be used with peer assessment / training.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Urmia Educational and Medical Centers affiliated to Urmia University of Medical Sciences
Full name of responsible person
Dr.Aram feizi
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
iran
Phone
+98 44 1293 7300
Email
aramfeizi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
iran
Phone
+98 44 1293 7300
Email
aramfeizi@yahoo.com
Grant name
Grant code / Reference number
.
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
iran
Phone
+98 44 1293 7300
Fax
Email
aramfeizi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
iran
Phone
+98 44 1293 7300
Fax
Email
aramfeizi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Dr. Aram Feizi
Position
PhD of Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Medical Education Development Center, Urmia University of Medical Sciences
City
Urmia
Province
West Azarbaijan
Postal code
iran
Phone
+98 44 1293 7300
Fax
Email
aramfeizi@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
.
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available